Imatinib Compared with Interferon and Low-Dose Cytarabine for Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
2003 · paper · Clinical trials
A randomized trial of 1106 patients with newly diagnosed chronic-phase chronic myeloid leukemia, comparing imatinib with interferon alfa plus low-dose cytarabine. Imatinib gave higher cytogenetic response rates, less progression and better tolerability.
2 findings
Wording Methods require "a diagnosis of chronic-phase, Ph-positive CML within six months before study entry", but Table 1 gives the range of "Interval since diagnosis — mo" as "0.0–10.4" (imatinib) and "0.0–8.0" (interferon alfa plus cytarabine).
- p. 2 Methods, Patients
agnosis of chronic-phase, Ph-positive CML within six months before study entry
- p. 4 Table 1, Interval since diagnosis — mo, Range
0.0–10.4
- p. 4 Table 1, Interval since diagnosis — mo, Range (interferon alfa plus cytarabine)
0.0–8.0
Only the authors can say what is right here.
Judge's note: Read page 2 (Patients) and Table 1 on page 4 from the page images; both values are as quoted. Searched the text for an explanation: Table 2 lists protocol violations (10 and 17) only as a reason for discontinuation and does not link them to eligibility, and nothing says the interval is measured to a date other than study entry. The mismatch is unexplained, so only the authors can say whether these were protocol violations.
Second check: another model agreed
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Wording Chronic phase is defined by "less than 20 percent basophils" (and accelerated phase by "at least 20 percent peripheral basophils"), but Table 1 gives the baseline range of peripheral-blood basophils as "0.0–39.0" and "0.0–26.0".
- p. 2 Methods, Patients
less than 20 percent basophils
- p. 4 Table 1, Peripheral-blood basophils — %, Range
0.0–39.0
- p. 4 Table 1, Peripheral-blood basophils — %, Range (interferon alfa plus cytarabine)
0.0–26.0
Only the authors can say what is right here.
Judge's note: Read page 2 (Patients), page 3 (End points) and Table 1 on page 4 from the page images. The basophil ranges exceed the chronic-phase limit in both groups. Table 1 also shows platelet minima of 47 and 18 ×10³/mm³ against the exclusion criterion of fewer than 100,000 platelets per cubic millimeter. No statement in the article explains this (for example protocol violations at entry, or different timing of screening and baseline samples). Unexplained mismatch for the authors to resolve.
Second check: another model agreed
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4 minor (typos and the like; most checked by the judge only)
Wording Discussion: "According to all variables measured, including the rates of complete hematologic response, major and complete cytogenetic response, freedom from progression to accelerated-phase or blast-crisis CML, and tolerance of therapy, imatinib was significantly superior", while survival is reported with "P=0.16" and "P=0.23" and the Discussion later says "We found no demonstrable difference in survival between the two groups".
- p. 8 Discussion, first paragraph
According to all variables measured
- p. 8 Results, Disease progression and survival
nation-therapy group (P=0.16)
- p. 9 Discussion
We found no demonstra-
- p. 8 Results, Disease progression and survival
95.1 percent for the combi- nation-therapy group (P=0.16)
Only the authors can say what is right here.
Judge's note: Read the Results and Discussion on the page 8 and page 9 images. Estimated 18-month survival is 97.2 versus 95.1 percent (P=0.16), and 97.4 versus 95.8 percent when censored at transplantation (P=0.23). The list after "including" omits survival, so the authors probably meant the named end points, but "all variables measured" is unqualified and the paper's own later sentence contradicts it. Wording overstatement only.
Second check: another model agreed
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Typo Table 3 lists "Rash 33.9" above "Fatigue 34.5" in the imatinib all-grades column, the only break in an otherwise descending order.
- p. 6 Table 3, left column imatinib all grades
Fatigue 34.5
- p. 6 Table 3, left block, imatinib all-grades column
Rash 33.9 ... Fatigue 34.5
Judge's note: Read Table 3 on the page 6 image. The left block runs 55.5, 43.7, 38.3, 36.5, 33.9, 34.5, 32.8, 31.2 and so on down to 8.5, and the right block is also descending (7.3 to 0.7). Only the Rash/Fatigue pair is out of order. The table does not state a sort rule, so this may be a row-order slip or a misprinted value; nothing else in the article gives either figure to check against.
Second check: none (judge only)
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Typo Presentation note reads "the annual meeting of the American Society for Clinical Oncology"; the society's name is given with "for" where "of" is expected.
- p. 10 Acknowledgment / presentation note
American Society
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that the organisation's name is the American Society of Clinical Oncology. The page 10 image prints "American Society for Clinical Oncology, Orlando, Fla., May 18–20, 2002" as quoted. Nothing in the files gives the society's name another way. Cosmetic.
Second check: none (judge only)
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Typo Appendix lists "I. Dahl (Trömso)" among the Norway investigators; the diacritic appears to be on the wrong vowel.
- p. 10 Appendix, Norway investigators
I. Dahl (Trömso)
Only the authors can say what is right here.
Judge's note: Rests on outside knowledge: that the Norwegian city is spelled Tromsø (or Tromsö), with the diacritic on the final vowel. The page 10 image shows "Trömso" as quoted, so this is not an extraction artefact. Cosmetic; the same list also prints "Malmo" and "Orebro" with no diacritics.
Second check: none (judge only)